Amyotrophic Lateral Sclerosis (ALS) Clinical Trial
Official title:
A Phase III, Multi-Center, Double-Blind, Placebo Controlled, Randomized Study of Creatine Monohydrate in Patients With Amyotrophic Lateral Sclerosis
The purpose of this study is to determine whether nine months of administration of creatine monohydrate results in an increase in muscle strength in patients with amyotrophic lateral sclerosis (ALS).
Introduction: Twenty-one ALS patients were enrolled in a placebo controlled pilot study at
the Carolinas Neuromuscular/ALS-MDA Center, The University of Texas Health Science Center at
San Antonio and The University of New Mexico at Albuquerque. At all time points sampled over
a nine month period, patients taking creatine monohydrate had either a significantly greater
improvement in their strength or a more modest decline compared to the patients taking
placebo. Overall analysis of variance is significant for both an effect of the drug
(p=0.002) and time (p< 0.001).The pilot study also showed that quality of life, as measured
by ALSFRS-R, correlated significantly with the observed changes in muscle strength (MVIC).
Phase III Study: The primary objective of this study is to determine whether treatment with
creatine monohydrate results in an increase in muscle strength relative to placebo in
patients with amyotrophic lateral sclerosis (ALS), after three months, and at the end of a
nine-month treatment period.
The study is a Phase III, eight-center, double-blind, placebo-controlled, randomized
clinical trial designed to evaluate the safety and efficacy of creatine monohydrate in
patients fulfilling the eligibility criteria. The subjects (n=156) will be randomized in a
1:1 ratio to receive treatment of highly purified creatine monohydrate or placebo (Dextrose,
USP) for nine months. The subjects will be administered 10 grams of creatine monohydrate per
day for the first five days, and then 5 grams per day thereafter. Each subject will be
followed for the nine-month treatment period.
The primary outcome measure for the study is change in upper extremity motor function after
three weeks, and at the end of a nine-month treatment period as tested by MVIC. Strength in
ten arm muscles will be measured (bilateral shoulder and elbow flexion/extension and grip).
Patient safety will be assured by ongoing review of reports of adverse events, clinical
laboratory data, and measurement of vital signs. These tests include: measurement of MVIC
and muscle fatigue, measurement of FVC, completion of ALSFRS-R and SF-12 quality of life
instruments, review of potential adverse effects, determination of vital signs and weight,
serum creatinine and BUN, and urine dipstick for protein.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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